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The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing

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ClinicalTrials.gov Identifier: NCT03057080
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Izolde Bouloukaki, University of Crete

Tracking Information
First Submitted Date  ICMJE February 12, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date February 17, 2017
Actual Study Start Date  ICMJE June 1, 2009
Actual Primary Completion Date June 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Number of patients with ulcer healing [ Time Frame: 2 years ]
Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Amputation free survival [ Time Frame: 2 years ]
    Number of months without amputation
  • Number of patients with all-cause mortality [ Time Frame: 2 years ]
    Number of patients with all-cause mortality after PTA
  • Number of participants with Major adverse events [ Time Frame: 2 years ]
    Number of participants with Major adverse events from PTA
  • Number of patients with 30-day morbidity and mortality [ Time Frame: 30 days ]
    30-day morbidity and mortality from PTA
  • Number of patients requiring re-intervention [ Time Frame: 2 years ]
    umber of patients requiring PTA re-intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
Official Title  ICMJE Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
Brief Summary The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.
Detailed Description

The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers.

Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Foot Ulcers
Intervention  ICMJE Procedure: Percutaneous transluminal angioplasty (PTA)
The main goal of the angioplasty (which was also the definition of technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or plantar arch.
Study Arms  ICMJE PTA procedure
Percutaneous transluminal angioplasty (PTA) in patients with ischemic leg ulcer
Intervention: Procedure: Percutaneous transluminal angioplasty (PTA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2017)
161
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2016
Actual Primary Completion Date June 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • newly diagnosed patients with ischemic foot ulcer and
  • patients aged 18 years or older.

Exclusion Criteria:

  • refusal to participate
  • refusal of PTA therapy
  • lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging
  • absolute contraindication to contrast media injection, as determined by the investigator
  • uncontrollable coagulopathy
  • unwilling or unable to provide informed consent or return for required follow-up evaluations and
  • previous or concurrent participation in another clinical research study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057080
Other Study ID Numbers  ICMJE PTA1A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Izolde Bouloukaki, University of Crete
Study Sponsor  ICMJE University of Crete
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dimitrios Tsetis, MD, PhD University of Crete
PRS Account University of Crete
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP